The Study to Assess AMI Treated With Balloon Angioplasty.

NCT00232830 | Completed Phase 3 DMC

• 1 other identifier: EC03-03
• Study Type: interventional
• Target: 715
• Locations: 2 countries
• Sites: 2

Brief Summary

The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.

  1 and 6 months and at 1, 3, 4, and 5 years post-procedure.

Secondary Outcomes (4)

• cardiac death

  1, 3, 4 and 5 years post-procedure

• recurrence of myocardial infarction

  1, 3, 4 and 5 years post-procedure

• revascularization of the target vessel (TVR)

  1, 3, 4 and 5 years post-procedure

• recurrence of ischemia

  1, 3, 4 and 5 years post-procedure

Study Arms (2)

1

EXPERIMENTAL

Cypher Sirolimus-eluting Coronary Stent

Device: drug-eluting stent

2

ACTIVE COMPARATOR

Bare-metal stent

Device: bare-metal stent

Interventions

drug-eluting stent DEVICE

Cypher Sirolimus-eluting Coronary Stent

1

bare-metal stent DEVICE

any bare-metal stent brand

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:
• ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
• New or presumably new left bundle branch block (LBBB)
• The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;

You may not qualify if:

• Killip class \> 2 upon arrival to the cath-lab;
• Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
• Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
• Documented left ventricular ejection fraction \<=30%;
• Target lesion is located in an arterial or venous by-pass graft;
• ECG documented evidence of prior myocardial infarction;
• Patient who received thrombolytic therapy for the current AMI before enrollment in this study.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

HOPITAL COCHIN, René Descartes University

Paris, 75014, France

Location

University of Freiburg, Albert-Ludwigs-Universitätskliniken

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (3)

• Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C; TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006 Sep 14;355(11):1093-104. doi: 10.1056/NEJMoa062006.

  PMID: 16971716 RESULT

• Rozenman Y, Witzling V, Tamari I, Turkisher V, Kriviski M, Bode C, Henry P, Teiger E, Cebrian A, Stoll HP, Spaulding C. Impact of stent length on restenosis in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: analysis based on data from the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). EuroIntervention. 2009 Jun;5(2):219-23. doi: 10.4244/eijv5i2a34.

  PMID: 19527979 RESULT

• Spaulding C, Teiger E, Commeau P, Varenne O, Bramucci E, Slama M, Beatt K, Tirouvanziam A, Polonski L, Stella PR, Clugston R, Fajadet J, de Boisgelin X, Bode C, Carrie D, Erglis A, Merkely B, Hosten S, Cebrian A, Wang P, Stoll HP, Henry P. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Cardiovasc Interv. 2011 Jan;4(1):14-23. doi: 10.1016/j.jcin.2010.10.007.

  PMID: 21251624 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Christian Spaulding, MD

  HOPITAL COCHIN, René Descartes University

  PRINCIPAL INVESTIGATOR

• Christoph Bode, MD

  University of Freiburg, Albert-Ludwigs-Universitätskliniken

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: October 1, 2003
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 16, 2009

Record last verified: 2009-04

Locations

FR (1); DE (1)